GxP Lifeline

Building Forms for Regulated Environments: Top 10 Best Practices

8 September, 2015 Cindy Fazzi, Editor, MasterControl Insider

It is important to build effective workflows in addition to designing robust forms.

Whether you’re applying for a job or a loan, or registering for a conference or membership in some organization, there’s one thing you must do—fill out a form. We can’t live without forms. In regulated environments, they are even more crucial because they can affect regulatory compliance.

Life science organizations under the jurisdiction of the U.S. Food and Drug Administration (FDA) use an array of forms such as corrective action and preventive action, complaint, and change control (engineering change request, design change request, etc.). These forms are necessary to gather, capture, and process data, which usually need to be reported and analyzed as part of compliance.

One of the biggest concerns for FDA-regulated companies is data integrity. “When updating or deleting data, users have to perform these actions in accordance with FDA regulations,” said Barry Michaelson, a process architect at MasterControl (1).“Though there is an audit trail, data can still be manipulated in such a manner that it presents inconsistencies.”

For example, 21 CFR Part 211 (for pharmaceutical companies) requires written production and process control procedures, which should be followed in execution. Any changes and deviations in those procedures should be documented, recorded, and justified.

Lance Johnson (2), director of MasterControl’s Technical Field Services Team (3),said that while forms are a key part of data collection, they don’t replace a workflow, so it’s important to build effective workflows in addition to designing robust forms.

Michaelson identified some of the problems that regulated companies encounter when building forms for compliance, such as not understanding how a system interacts with HTML forms, not knowing how the system’s keywords work, and developing an effective route.

“Having disorganized content is a common pitfall,” added Johnson. His advice is to always keep in mind how end users will likely enter data.

If you build forms for compliance purposes or if your work involves forms-based processes, Michaelson and Johnson shared these best practices:

1. Simplicity is still the best policy, especially in building forms. Use standard fonts and colors.
2. Avoid long lists of fields. Break the form up into sections according to the type of data you are collecting (i.e., product, supplier, containment). Consider who will interact with the form, and in what order data is likely to be entered.

3. The form is not the process. Use the form as part of a process.

4. Make your form more relevant to the user by making it easier to input at appropriate places.

6. Be conscientious about gathering user requirements. The best built form that doesn’t fulfill users’ needs provides little value.

7. Get a prototype in front of the users as soon as reasonably possible. It’s easier for users to know what they want when they can see it.

8. Let users test your form. They are likely to find things that you didn’t anticipate.

9. Get software-specific training in addition to learning HTML, JavaScript, jQuery, and Ajax. There are certain things unique to the software that designers need to know to create a form.

10. Upgrade to the latest version of your system to leverage enhancements.

References:

This article is based on a white paper, “Top 10 Best Practices for Building Forms.” If you want to read more about these best practices, download the complimentary white paper.(1) Barry Michaelson develops processes and design requirements documentation for customers, develops HTML web pages for use in MasterControl software, and automates HTML web pages using various programming languages (JavaScript, jQuery, Ajax, JSON, etc.). His extensive technology experience includes working for Moog Medical Device Group, Zevex, and Affiliated Computer Systems. He has worked with over 60 regulated companies, mostly in customizing forms, since he joined MasterControl in 2013.

(2) Lance Johnson, who joined MasterControl in 2005, works closely with customers in defining, mapping, and optimizing critical business processes. He has implemented over 200 software projects.

(3) MasterControl solution packages include ready-to-use data collection forms. However, companies with unique compliance or business needs can choose to engage the services of the Technical Field Services Team to customize their forms.

Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.